Study of Safety and Tolerability of Intravenous CRS-100 in Adults With Carcinoma and Liver Metastases

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CRS-100

About this trial

This is an interventional treatment trial for Neoplasm Metastasis focused on measuring carcinoma, liver, hepatic, metastasis, Listeria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (abbreviated): Documented carcinoma refractory to standard treatment (or for whom no standard treatment is available). Hepatocellular carcinoma (HCC) is not allowed. Hepatic metastases ECOG Performance Status of 0 or 1, or Karnofsky Performance Status (KPS) of 80% to 100%. Adequate organ function as defined by clinical hematology and chemistry assays. Exclusion Criteria (abbreviated): Known central nervous system metastases. History of allergic reactions attributed to sulfa or beta-lactam antibiotics. Cardiac conditions associated with high- or moderate-risk of endocarditis. Intra-arterial hepatic catheter, hepatic cirrhosis, or clinically relevant ascites. Artificial (prosthetic) joint or other artificial implant or devices that cannot easily be removed. Known coagulation disorder or recent thromboembolic event. Use of immunosuppressive agent, chemotherapy, or radiation therapy within 28 days prior to CRS-100; bone marrow or stem cell transplant or a major organ allograft; autoimmune disease. Current history of gallstones or kidney stones. Infection with HIV, human t-lymphotropic virus type 1 (HTLV-1), hepatitis c virus (HCV), or hepatitis b virus (HBV). Pregnant or lactating

Sites / Locations

Johns Hopkins University
Mary Crowley Medical Research Center

Outcomes

Primary Outcome Measures

Dose-limiting toxicities (DLTs) for 7 days after dosing

Secondary Outcome Measures

Full Information

NCT ID

NCT00327652

First Posted

May 17, 2006

Last Updated

April 22, 2008

Sponsor

Anza Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00327652

Brief Title

Study of Safety and Tolerability of Intravenous CRS-100 in Adults With Carcinoma and Liver Metastases

Official Title

Phase 1 Dose-Escalation Study of Safety and Tolerability of Intravenous CRS-100 in Adults With Carcinoma and Liver Metastases

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Anza Therapeutics, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This clinical trial evaluated the safety and tolerability of CRS-100, an investigational agent containing a live-attenuated strain of Listeria monocytogenes (Lm). CRS-100 is attenuated by genetic modification to limit cell to cell spread and invasion of liver cells. These attenuations result in decreased virulence of CRS-100 in mice but retain the ability of the investigational agent to stimulate immunity in test animals and generate anti-tumor activity in mice. The primary objective of this study was to determine the maximum tolerated dose (MTD) and to explore the safety profile of a single intravenous dose of CRS-100 in consenting volunteers. Immunological response to CRS-100 and tumor status of study participants were also measured. Participation in this first clinical trial with CRS-100 was restricted to adults with carcinoma refractory to standard treatment (or for whom no standard treatment is available) and who additionally had liver metastases.

Detailed Description

Patients who consented to participate in the study were evaluated for eligibility according to their medical history, physical examination, blood testing, and computed tomography (CT) scan of thorax, abdomen, and pelvis. Those patients who qualified for the study received a single intravenous dose of CRS-100 on study day 1, after which they remained in the hospital for five days for safety monitoring of health status, including serial blood collections. Study participants returned for out-patient follow-up for further blood tests and additional monitoring of safety and immune response to CRS-100. At day 56, after administration of CRS-100, participants had a repeat CT scan to measure tumor size, and they were then discharged from the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neoplasm Metastasis, Liver Neoplasms, Carcinoma

Keywords

carcinoma, liver, hepatic, metastasis, Listeria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

CRS-100

Intervention Description

Live-attenuated Listeria monocytogenes

Primary Outcome Measure Information:

Title

Dose-limiting toxicities (DLTs) for 7 days after dosing

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria (abbreviated): Documented carcinoma refractory to standard treatment (or for whom no standard treatment is available). Hepatocellular carcinoma (HCC) is not allowed. Hepatic metastases ECOG Performance Status of 0 or 1, or Karnofsky Performance Status (KPS) of 80% to 100%. Adequate organ function as defined by clinical hematology and chemistry assays. Exclusion Criteria (abbreviated): Known central nervous system metastases. History of allergic reactions attributed to sulfa or beta-lactam antibiotics. Cardiac conditions associated with high- or moderate-risk of endocarditis. Intra-arterial hepatic catheter, hepatic cirrhosis, or clinically relevant ascites. Artificial (prosthetic) joint or other artificial implant or devices that cannot easily be removed. Known coagulation disorder or recent thromboembolic event. Use of immunosuppressive agent, chemotherapy, or radiation therapy within 28 days prior to CRS-100; bone marrow or stem cell transplant or a major organ allograft; autoimmune disease. Current history of gallstones or kidney stones. Infection with HIV, human t-lymphotropic virus type 1 (HTLV-1), hepatitis c virus (HCV), or hepatitis b virus (HBV). Pregnant or lactating

Facility Information:

Facility Name

Johns Hopkins University

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231

Country

United States

Facility Name

Mary Crowley Medical Research Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75201

Country

United States

Neoplasm Metastasis, Liver Neoplasms, Carcinoma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial